Tissue fixation devices and methods

ABSTRACT

The present disclosure describes tissue gripping devices, systems, and methods for gripping mitral valve tissue during treatment of a mitral valve and while a tissue fixation device is implanted in the mitral valve. The tissue gripping device includes a flexible member and one or more tissue gripping members coupled to one or more arms of the flexible member. The flexible member is formed from a shape-memory material, such as nitinol, and the tissue gripping member(s) are formed from a material that is more rigid than the shape-memory material. The tissue gripping member(s) are attached to the flexible member by threading or looping suture lines around and/or through the tissue gripping member(s) and the flexible member and/or by applying a cover material to the tissue gripping device to hold the tissue gripping member(s) against the flexible member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/050,445, filed Jul. 31, 2018, now allowed, which is a continuation ofU.S. patent application Ser. No. 14/677,294, filed Apr. 2, 2015, nowU.S. Pat. No. 10,524,912, the entire contents of which are incorporatedby reference herein

BACKGROUND

The present invention relates generally to medical methods, devices, andsystems. In particular, the present invention relates to methods,devices, and systems for the endovascular, percutaneous or minimallyinvasive surgical treatment of bodily tissues, such as tissueapproximation or valve repair. More particularly, the present inventionrelates to repair of valves of the heart and venous valves, and devicesand methods for removing or disabling mitral valve repair componentsthrough minimally invasive procedures.

Surgical repair of bodily tissues often involves tissue approximationand fastening of such tissues in the approximated arrangement. Whenrepairing valves, tissue approximation often includes coapting theleaflets of the valves in a therapeutic arrangement which may then bemaintained by fastening or fixing the leaflets. Such fixation of theleaflets can be used to treat regurgitation which most commonly occursin the mitral valve.

Mitral valve regurgitation is characterized by retrograde flow from theleft ventricle of a heart through an incompetent mitral valve into theleft atrium. During a normal cycle of heart contraction (systole), themitral valve acts as a check valve to prevent flow of oxygenated bloodback into the left atrium. In this way, the oxygenated blood is pumpedinto the aorta through the aortic valve. Regurgitation of the valve cansignificantly decrease the pumping efficiency of the heart, placing thepatient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve or the left ventricular wall. Thevalve leaflets, the valve chordae which connect the leaflets to thepapillary muscles, the papillary muscles themselves, or the leftventricular wall may be damaged or otherwise dysfunctional. Commonly,the valve annulus may be damaged, dilated, or weakened, limiting theability of the mitral valve to close adequately against the highpressures of the left ventricle during systole.

The most common treatments for mitral valve regurgitation rely on valvereplacement or repair including leaflet and annulus remodeling, thelatter generally referred to as valve annuloplasty. One technique formitral valve repair which relies on suturing adjacent segments of theopposed valve leaflets together is referred to as the “bow-tie” or“edge-to-edge” technique. While all these techniques can be effective,they usually rely on open heart surgery where the patient's chest isopened, typically via a sternotomy, and the patient placed oncardiopulmonary bypass. The need to both open the chest and place thepatient on bypass is traumatic and has associated high mortality andmorbidity.

In some patients, a fixation device can be installed into the heartusing minimally invasive techniques. The fixation device can hold theadjacent segments of the opposed valve leaflets together to reducemitral valve regurgitation. One such device used to clip the anteriorand posterior leaflets of the mitral valve together is the MitraClip®fixation device, sold by Abbott Vascular, Santa Clara, Calif., USA.

These fixation devices often include clips designed to grip and holdagainst tissue as the clip arms are moved and positioned against thetissue at the treatment site and then closed against the tissue. Suchclips are designed to continue gripping the tissue as the fixationdevice is closed into a final position. In order to achieve this effect,such these clips are sometimes equipped with barbs or hooks to grip thetissue as the clip is flexed into position against the tissue.

However, some tissue fixation treatments require a fixation device tomove through a wide range of grasping angles in order to be properlypositioned relative to the target tissue and then to grasp the tissueand bring it to a closed position. This moving and plastically deformingcomponents of the fixation device during positioning and closure of thedevice can lead to the weakening and pre-mature degradation of thefixation device. Additionally, some tissue fixation treatments requirethat the fixation device maintain a degree of flexibility and mobilityto allow a range of physiological movement even after the device hasbeen properly placed and the target tissue has been properly fixed intothe desired position, This can increase the risk of pre-mature failureof the device as continued plastic deformation of the flexing components(e.g., from the continuous opening and closing of valve leaflets) leadsto unfavorable degradation of the device.

For these reasons, there is an ongoing need to provide alternative andadditional methods, devices, and systems for tissue fixation thatprovide beneficial elasticity and durability of the flexing componentswithout unduly increasing the associated manufacturing costs of theflexing components. There is also a need to provide such methods,devices, and systems in a manner that does not limit the tissue grippingability of the tissue fixation device. At least some of the embodimentsdisclosed below are directed toward these objectives.

DESCRIPTION OF THE BACKGROUND ART

Minimally invasive and percutaneous techniques for coapting andmodifying mitral valve leaflets to treat mitral valve regurgitation aredescribed in PCT Publication Nos. WO 98/35638; WO 99/00059; WO 99/01377;and WO 00/03759; WO 2000/060995; WO 2004/103162. Maisano et al. (1998)Eur. J. Cardiothorac. Surg. 13:240-246; Fucci et al. (1995) Eur. J.Cardiothorac. Surg. 9:621-627; and Umana et al. (1998) Ann. Thorac.Surg. 66:1640-1646, describe open surgical procedures for performing“edge-to-edge” or “bow-tie” mitral valve repair where edges of theopposed valve leaflets are sutured together to lessen regurgitation. Decand Fuster (1994) N. Engl. J. Med. 331:1564-1575 and Alvarez et al.(1996) J. Thorac. Cardiovasc. Surg. 112:238-247 are review articlesdiscussing the nature of and treatments for dilated cardiomyopathy.

Mitral valve annuloplasty is described in the following publications:Bach and Bolling (1996) Am. J. Cardiol. 78:966-969; Kameda et al. (1996)Ann. Thorac. Surg. 61:1829-1832; Bach and Bolling (1995) Am. Heart J.129:1165-1170; and Bolling et al. (1995) 109:676-683. Linear segmentalannuloplasty for mitral valve repair is described in Ricchi et al.(1997) Ann. Thorac. Surg. 63:1805-1806. Tricuspid valve annuloplasty isdescribed in McCarthy and Cosgrove (1997) Ann. Thorac. Surg. 64:267-268;Tager et al. (1998) Am. J. Cardiol. 81:1013-1016; and Abe et al. (1989)Ann. Thorac. Surg. 48:670-676.

Percutaneous transluminal cardiac repair procedures are described inPark et al. (1978) Circulation 58:600-608; Uchida et al. (1991) Am.Heart J. 121: 1221-1224; and Ali Khan et al. (1991) Cathet. Cardiovasc.Diagn. 23:257-262. Endovascular cardiac valve replacement is describedin U.S. Pat. Nos. 5,840,081; 5,411,552; 5,554,185; 5,332,402; 4,994,077;and 4,056,854. U.S. Pat. No. 3,671,979 describes a catheter fortemporary placement of an artificial heart valve.

Other percutaneous and endovascular cardiac repair procedures aredescribed in U.S. Pat. Nos. 4,917,089; 4,484,579; and 3,874,338; and PCTPublication No. WO 91/01689.

Thoracoscopic and other minimally invasive heart valve repair andreplacement procedures are described in U.S. Pat. Nos. 5,855,614;5,829,447; 5,823,956; 5,797,960; 5,769,812; and 5,718,725.

BRIEF SUMMARY

The present disclosure describes methods and devices for gripping tissuein a tissue repair and/or fixation procedure, such as in a mitral valverepair procedure. Certain embodiments of a tissue gripping deviceinclude a flexible member formed from a shape-memory material, theflexible member comprising a base section and an arm, the arm having afirst end connected to the base section, a free end extending away fromthe base section, and an attachment surface disposed between the joiningend and the free end, and at least one tissue gripping member formedfrom a second material, the second material being more rigid than theshape-memory material, the tissue gripping member comprising a matingsurface coupled to the attachment surface of the arm to join the tissuegripping member to the flexible member, and a tissue gripping surfacedisposed opposite the mating surface, the tissue gripping surfaceincluding a frictional element configured to resist movement of tissueaway from the tissue gripping surface after the tissue has contacted thetissue gripping surface.

Certain embodiments of a tissue fixation system configured forintravascular delivery and for use in joining mitral valve tissue fortreatment of the mitral valve include: a body; a proximal elementcomprising a flexible member formed from a shape-memory material, theflexible member comprising a base section and an arm, the arm having afirst end connected to the base section, a free end extending away fromthe base section, and an attachment surface disposed between the joiningend and the free end, and at least one tissue gripping member formedfrom a second material, the second material being more rigid than theshape-memory material, the tissue gripping member comprising a matingsurface coupled to the attachment surface of the arm to join the tissuegripping member to the flexible member, and a tissue gripping surfacedisposed opposite the mating surface, the tissue gripping surfaceincluding a frictional element configured to resist movement of tissueaway from the tissue gripping surface after the tissue has contacted thetissue gripping surface; and a distal element having a first endpivotally coupled to the body and extending to a free second end and atissue engagement surface between the first and second end, the tissueengagement surface being configured to approximate and engage a portionof the leaflets of the mitral valve, wherein the proximal element isconfigured to cooperate with the distal element to form a space forreceiving a portion of mitral valve tissue therebetween.

Certain embodiments of a method of manufacturing a tissue grippingdevice of the present disclosure include: forming a flexible member froma shape-memory alloy by cutting a pattern shape and heat shape settingat least one bend feature, the flexible member comprising a base sectionand an arm, the arm having a first end connected to the base section, afree end extending away from the base section, and an attachment surfacedisposed between the joining end and the free end, the at least one bendfeature being disposed between the first end and the free end of thearm; forming a tissue gripping member from a second material by diestamping the second material to form a plurality of raised barbs and aplurality of slotted recesses along the side edge of the tissue grippingmember, the second material being more rigid than the shape-memorymaterial, the tissue gripping member comprising a mating surface and atissue gripping surface disposed opposite the mating surface; andattaching the tissue gripping member to the flexible member by couplingthe mating surface of the tissue gripping member to the attachmentsurface of the arm.

Certain embodiments provide advantages and benefits over tissue grippingdevices, systems, and methods of the prior art. For example, providing aflexible member formed from a shape-memory material may providesuperelasticity over the wide range of grasping angles covered duringpositioning of a tissue gripping device at a treatment site, such asduring mitral valve leaflet grasp attempts during a mitral valve repairprocedure. Additionally, avoiding plastic deformation of the flexiblemember during positioning and/or during post-implanting movement canincrease the function and/or life of the device. Furthermore,embodiments providing one or more tissue gripping members formed from asecond material can provide easier and more cost-effective manufacturingof tissue gripping frictional elements and other features of the tissuegripping member(s) as opposed to forming them using a shape-memorymaterial, such as by forming them directly on the flexible member.Certain embodiment may therefore provide the benefits of superelasticproperties where such properties are desired, while simultaneouslyproviding more rigidity and/or easier manufacturability where suchproperties are desired.

These and other objects and features of the present disclosure willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent disclosure, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. Embodiments of theinvention will be described and explained with additional specificityand detail through the use of the accompanying drawings in which:

FIG. 1 illustrates free edges of leaflets of the mitral valve in normalcoaptation, and FIG. 2 illustrates the free edges in regurgitativecoaptation;

FIGS. 3A-3C illustrate grasping of the leaflets with a fixationassembly, inversion of the distal elements of the fixation assembly andremoval of the fixation assembly, respectively;

FIG. 4 illustrates the fixation assembly in a desired orientationrelative to the leaflets;

FIG. 5 illustrates an exemplary fixation assembly coupled to a shaft;

FIGS. 6A-6B, 7A-7C, and 8 illustrate a fixation assembly in variouspossible positions during introduction and placement of the assemblywithin the body to perform a therapeutic procedure;

FIGS. 9A-9C illustrate detailed views of a proximal element of a tissuefixation device, the proximal element including a flexible member and aplurality of tissue gripping members;

FIGS. 10A-10C illustrate detailed views of a proximal element of atissue fixation device, with a plurality of tissue gripping membersjoined to a flexible member by suture lines; and

FIGS. 11A-11C illustrate detailed views of a proximal element of atissue fixation device, the proximal element having a cover, and aplurality of tissue gripping members held against a flexible member bythe cover.

DETAILED DESCRIPTION I. Cardiac Physiology

As shown in FIG. 1, the mitral valve (MV) comprises a pair of leaflets(LF) having free edges (FE) which, in patients with normal heartstructure and function, meet evenly to close along a line of coaption(C). The leaflets (LF) attach to the surrounding heart structure alongan annular region called the annulus (AN). The free edges (FE) of theleaflets (LF) are secured to the lower portions of the left ventricle LVthrough chordae tendinae (or “chordae”). As the left ventricle of aheart contracts (which is called “systole”), blood flow from the leftventricle to the left atrium through the mitral valve (MV) (called“mitral regurgitation”) is usually prevented by the mitral valve.Regurgitation occurs when the valve leaflets do not close properly andallow leakage from the left ventricle into the left atrium. A number ofheart structural defects can cause mitral regurgitation. FIG. 2 shows amitral valve with a defect causing regurgitation through a gap (G).

II. Overview of Mitral Valve Fixation System

Several methods for repairing or replacing a defective mitral valveexist. Some defects in the mitral valve can be treated throughintravascular procedures, where interventional tools and devices areintroduced and removed from the heart through the blood vessels. Onemethod of repairing certain mitral valve defects includes intravasculardelivery of a fixation device to hold portions of the mitral valvetissues in a certain position. One or more interventional catheters maybe used to deliver a fixation device to the mitral valve and install itthere as an implant to treat mitral regurgitation.

FIG. 3A illustrates a schematic of an interventional tool 10 with adelivery shaft 12 and a fixation device 14. The tool 10 has approachedthe mitral valve MV from the atrial side and grasped the leaflets LF.The fixation device 14 is releasably attached to the shaft 12 of theinterventional tool 10 at the distal end of the shaft 12. In thisapplication, when describing devices, “proximal” means the directiontoward the end of the device to be manipulated by the user outside thepatient's body, and “distal” means the direction toward the working endof the device that is positioned at the treatment site and away from theuser. When describing the mitral valve, proximal means the atrial sideof the leaflets and distal means the ventricular side of the leaflets.The fixation device 14 comprises proximal elements 16 and distalelements 18 which protrude radially outward and are positionable onopposite sides of the leaflets LF as shown so as to capture or retainthe leaflets therebetween. The fixation device 14 is coupleable to theshaft 12 by a coupling mechanism 17.

FIG. 3B illustrates that the distal elements 18 may be moved in thedirection of arrows 40 to an inverted position. The proximal elements 16may be raised as shown in FIG. 3C. In the inverted position, the device14 may be repositioned and then be reverted to a grasping positionagainst the leaflets as in FIG. 3A. Or, the fixation device 14 may bewithdrawn (indicated by arrow 42) from the leaflets as shown in FIG. 3C.Such inversion reduces trauma to the leaflets and minimizes anyentanglement of the device with surrounding tissues.

FIG. 4 illustrates the fixation device 14 in a desired orientation inrelation to the leaflets LF. The mitral valve MV is viewed from theatrial side, so the proximal elements 16 are shown in solid line and thedistal elements 18 are shown in dashed line. The proximal and distalelements 16, 18 are positioned to be substantially perpendicular to theline of coaptation C. During diastole (when blood is flowing from theleft atrium to the left ventricle), fixation device 14 holds theleaflets LF in position between the elements 16, 18 surrounded byopenings or orifices O which result from the diastolic pressuregradient, as shown in FIG. 4. Once the leaflets are coapted in thedesired arrangement, the fixation device 14 is detached from the shaft12 and left behind as an implant.

FIG. 5 illustrates an exemplary fixation device 14. The fixation device14 is shown coupled to a shaft 12 to form an interventional tool 10. Thefixation device 14 includes a coupling member 19, a pair of opposedproximal elements 16, and a pair of opposed distal elements 18. Thedistal elements 18 comprise elongate arms 53, each arm having a proximalend 52 rotatably connected to the coupling member 19 and a free end 54.Preferably, each free end 54 defines a curvature about two axes, axis 66perpendicular to longitudinal axis of arms 53, and axis 67 perpendicularto axis 66 or the longitudinal axis of arms 53. Arms 53 have engagementsurfaces 50. Arms 53 and engagement surfaces 50 are configured to engageabout 4-10 mm of tissue, and preferably about 6-8 mm along thelongitudinal axis of arms 53. Arms 53 further include a plurality ofopenings.

The proximal elements 16 are preferably resiliently biased toward thedistal elements 18. When the fixation device 14 is in the open position,each proximal element 16 is separated from the engagement surface 50near the proximal end 52 of arm 53 and slopes toward the engagementsurface 50 near the free end 54 with the free end of the proximalelement 16 contacting engagement surface 50, as illustrated in FIG. 5.Proximal elements 16 include a plurality of openings 63 and scallopedside edges 61 to increase their grip on tissue. The proximal elements 16optionally include a frictional element or multiple frictional elementsto assist in grasping the leaflets. The frictional elements may comprisebarbs 60 having tapering pointed tips extending toward engagementsurfaces 50. Any suitable frictional elements may be used, such asprongs, windings, bands, barbs, grooves, channels, bumps, surfaceroughening, sintering, high-friction pads, coverings, coatings or acombination of these. The proximal elements 16 may be covered with afabric or other flexible material. Preferably, when fabrics or coveringsare used in combination with barbs or other frictional features, suchfeatures will protrude through such fabric or other covering so as tocontact any tissue engaged by proximal elements 16.

The fixation device 14 also includes an actuator or actuation mechanism58. The actuation mechanism 58 comprises two link members or legs 68,each leg 68 having a first end 70 which is rotatably joined with one ofthe distal elements 18 at a riveted joint 76 and a second end 72 whichis rotatably joined with a stud 74. The actuation mechanism 58 comprisestwo legs 68 which are each movably coupled to a base 69. Or, each leg 68may be individually attached to the stud 74 by a separate rivet or pin.The stud 74 is joinable with an actuator rod which extends through theshaft 12 and is axially extendable and retractable to move the stud 74and therefore the legs 68 which rotate the distal elements 18 betweenclosed, open and inverted positions. Immobilization of the stud 74 holdsthe legs 68 in place and therefore holds the distal elements 18 in adesired position. The stud 74 may also be locked in place by a lockingfeature. This actuator rod and stud assembly may be considered a firstmeans for selectively moving the distal elements between a firstposition in which the distal elements are in a collapsed, low profileconfiguration for delivery of the device, a second position in which thedistal elements are in an expanded configuration for positioning thedevice relative to the mitral valve, and a third position in which thedistal elements are secured in position against a portion of theleaflets adjacent the mitral valve on the ventricular side.

FIGS. 6A-6B, 7A-7C, and 8 illustrate various possible positions of thefixation device 14 of FIG. 5. FIG. 6A illustrates an interventional tool10 delivered through a catheter 86. The catheter 86 may take the form ofa guide catheter or sheath. The interventional tool 10 comprises afixation device 14 coupled to a shaft 12 and the fixation device 14 isshown in the closed position.

FIG. 6B illustrates a device similar to the device of FIG. 6A in alarger view. In the closed position, the opposed pair of distal elements18 are positioned so that the engagement surfaces 50 face each other.Each distal element 18 comprises an elongate arm 53 having a cupped orconcave shape so that together the arms 53 surround the shaft 12. Thisprovides a low profile for the fixation device 14.

FIGS. 7A-7B illustrate the fixation device 14 in the open position. Inthe open position, the distal elements 18 are rotated so that theengagement surfaces 50 face a first direction. Distal advancement of theactuator rod relative to shaft 12, and thus distal advancement of thestud 74 relative to coupling member 19, applies force to the distalelements 18 which begin to rotate around joints 76. Such rotation andmovement of the distal elements 18 radially outward causes rotation ofthe legs 68 about joints 80 so that the legs 68 are directed slightlyoutwards. The stud 74 may be advanced to any desired distancecorrelating to a desired separation of the distal elements 18. In theopen position, engagement surfaces 50 are disposed at an acute anglerelative to shaft 12, and are preferably at an angle of between 90 and180 degrees relative to each other. In the open position, the free ends54 of arms 53 may have a span therebetween of about 10-20 mm, usuallyabout 12-18 mm, and preferably about 14-16 mm.

Proximal elements 16 are typically biased outwardly toward arms 53. Theproximal elements 16 may be moved inwardly toward the shaft 12 and heldagainst the shaft 12 with the aid of proximal element lines 90 which canbe in the form of sutures, wires, nitinol wire, rods, cables, polymericlines, or other suitable structures. The proximal element lines 90extend through the shaft 302 of the delivery catheter 300 and connectwith the proximal elements 16. The proximal elements 16 are raised andlowered by manipulation of the proximal element lines 90. For example,FIG. 7C illustrates proximal elements 16 in a lowered position as aresult of providing slack to proximal element lines 90. Once the deviceis properly positioned and deployed, the proximal element lines can beremoved by withdrawing them through the catheter and out the proximalend of the device 10. The proximal element lines 90 may be considered asecond means for selectively moving the proximal elements between afirst position in which the proximal elements are in a collapsed, lowprofile configuration for delivery of the device and a second positionin which the proximal elements are in an expanded configuration forengaging a portion of the leaflets adjacent the mitral valve on theatrial side.

In the open position, the fixation device 14 can engage the tissue whichis to be approximated or treated. The interventional tool 10 is advancedthrough the mitral valve from the left atrium to the left ventricle. Thedistal elements 18 are then deployed by advancing actuator rod relativeto shaft 12 to thereby reorient distal elements 18 to be perpendicularto the line of coaptation. The entire assembly is then withdrawnproximally and positioned so that the engagement surfaces 50 contact theventricular surface of the valve leaflets, thereby engaging the leftventricle side surfaces of the leaflets. The proximal elements 16 remainon the atrial side of the valve leaflets so that the leaflets liebetween the proximal and distal elements. The interventional tool 10 maybe repeatedly manipulated to reposition the fixation device 14 so thatthe leaflets are properly contacted or grasped at a desired location.Repositioning is achieved with the fixation device in the open position.In some instances, regurgitation may also be checked while the device 14is in the open position. If regurgitation is not satisfactorily reduced,the device may be repositioned and regurgitation checked again until thedesired results are achieved.

It may also be desired to invert distal elements 18 of the fixationdevice 14 to aid in repositioning or removal of the fixation device 14.FIG. 8 illustrates the fixation device 14 in the inverted position. Byfurther advancement of actuator rod relative to shaft 12, and thus stud74 relative to coupling member 19, the distal elements 18 are furtherrotated so that the engagement surfaces 50 face outwardly and free ends54 point distally, with each arm 53 forming an obtuse angle relative toshaft 12.

The angle between arms 53 when the device is inverted is preferably inthe range of about 270 to 360 degrees. Further advancement of the stud74 further rotates the distal elements 18 around joints 76. Thisrotation and movement of the distal elements 18 radially outward causesrotation of the legs 68 about joints 80 so that the legs 68 are returnedtoward their initial position, generally parallel to each other. Thestud 74 may be advanced to any desired distance correlating to a desiredinversion of the distal elements 18. Preferably, in the fully invertedposition, the span between free ends 54 is no more than about 20 mm,usually less than about 16 mm, and preferably about 12-14 mm. Barbs 60are angled slightly in the distal direction (away from the free ends ofthe proximal elements 16), reducing the risk that the barbs will catchon or lacerate tissue as the fixation device is withdrawn.

Once the distal elements 18 of the fixation device 14 have beenpositioned in a desired location against the left ventricle sidesurfaces of the valve leaflets, the leaflets may then be capturedbetween the proximal elements 16 and the distal elements 18. Theproximal elements 16 are lowered toward the engagement surfaces 50 byreleasing tension from proximal element lines 90, thereby releasingproximal elements 16 so that they are then free to move, in response tothe internal spring bias force formed into proximal elements 16, from aconstrained, collapsed position to an expanded, deployed position and sothat the leaflets are held between the proximal elements 16 and thedistal elements 18. If regurgitation is not sufficiently reduced, theproximal elements 16 may be raised and the distal elements 18 adjustedor inverted to reposition the fixation device 14.

After the leaflets have been captured between the proximal and distalelements 16, 18 in a desired arrangement, the distal elements 18 may belocked to hold the leaflets LF in this position or the fixation device14 may be returned to or toward a closed position. This is achieved byretraction of the stud 74 proximally relative to coupling member 19 sothat the legs 68 of the actuation mechanism 58 apply an upwards force tothe distal elements 18 which in turn rotate the distal elements 18 sothat the engagement surfaces 50 again face one another. The releasedproximal elements 16 which are biased outwardly toward distal elements18 are concurrently urged inwardly by the distal elements 18. Thefixation device 14 may then be locked to hold the leaflets in thisclosed position. The fixation device 14 may then be released from theshaft 12.

The fixation device 14 optionally includes a locking mechanism forlocking the device 14 in a particular position, such as an open, closedor inverted position or any position therebetween. The locking mechanismmay include a release harness. Applying tension to the release harnessmay unlock the locking mechanism. The lock lines 92 engage the releaseharnesses 108 of the locking mechanism 106 to lock and unlock thelocking mechanism 106. The lock lines 92 extend through the shaft 302 ofthe delivery catheter 300. A handle attached to the proximal end of theshaft is used to manipulate and decouple the fixation device 14.

Additional disclosure regarding such fixation devices 14 may be found inPCT Publication No. WO 2004/103162 and U.S. patent application Ser. No.14/216,787, the disclosures of both of which are incorporated herein intheir entirety.

III. Improved Tissue Fixation Device

Certain embodiments of tissue fixation devices of the present disclosureinclude a proximal element 16 formed as a tissue gripping device asdescribed in detail below. In some embodiments, a tissue gripping devicecan form the proximal element 16 of a tissue fixation device (such asany of the tissue fixation devices 14 described above with reference toFIGS. 3-8 and related discussion), and can be utilized as the proximalelement 16 of the tissue fixation device. The terms “tissue grippingdevice” and “proximal element” or “proximal elements,” as definedherein, are therefore interchangeable.

FIGS. 9A-9C illustrate an embodiment of a tissue gripping device 100including a flexible member 102 and at least one tissue gripping member122 (e.g., a pair of tissue gripping members 122 as illustrated) coupledto the flexible member 102. The flexible member 102 may be formed from afirst material and the tissue gripping member 122 may be formed from asecond, different material. In preferred embodiments, the secondmaterial has greater rigidity than the first material, making the tissuegripping member 122 more rigid than the flexible member 102.Accordingly, in such embodiments, the flexible member 102 is moreflexible than the tissue gripping member 122. The flexible member 102 ispreferably made from a shape-memory material such as nitinol. In thisconfiguration, flexible member 102 exhibits superelasticity duringflexing, bending, and/or otherwise positioning the tissue grippingdevice 100 (e.g., such as during positioning and deployment of thedevice at a treatment site and/or during continued movement after beingdeployed).

For example, during a mitral valve repair procedure, portions of thetissue gripping device may need to repeatedly pass through wide anglesas multiple tissue grasping attempts are made and/or as the tissuegripping device 100 is moved into an acceptable position against theleaflets of the mitral valve. Furthermore, even after deployment againstmitral valve tissue, the tissue gripping device 100 may need to providesome amount of flexibility and movement as the repaired mitral valvetissue continues to move during cardiac cycles. Forming the flexiblemember 102 from a shape-memory material such as nitinol avoids plasticdeformation of the flexible member 102 during these movements, therebypromoting easier tissue grasping during deployment and reducingmechanical degradation of the tissue gripping device 100 from repeatedand/or high levels of plastic deformation.

The tissue gripping member 122 can be formed from stainless steel or acobalt-chromium alloy, such as a cobalt-chromium-nickel alloy or acobalt-chromium-nickel-iron-molybdenum-manganese alloy. In preferredembodiments, the tissue gripping member 122 is formed from Elgiloy®,however, any suitable material or combinations of materials may be used.For example, a tissue gripping member 122 may be formed from a materialin which frictional elements 128 (e.g., raised barbs) or other featuresof the tissue gripping member(s) are easily machined or otherwise formed(e.g., more easily machined relative to machining such features using ashape-memory material such as with machining frictional elements 128directly onto the arms 106 of the flexible member 102).

The flexible member 102 includes a proximal side 114, a distal side 116,a base section 104, and a pair of arms 106, with each arm 106 extendingfrom the base section 104 to a free end 108. In other embodiments, theremay be one arm extending from a base section, or there may be more thantwo arms extending from a base section. For example, some embodimentsmay have multiple arms arrayed about a base section (e.g., in a radialfashion), and/or may include a first plurality of arms disposed oppositea second plurality of arms.

Each arm in the illustrated embodiment includes a first bend feature 110disposed at an area adjacent to the base section 104, and a second bendfeature 112 disposed a distance farther toward the free end 106 from thefirst bend feature 110. The first bend features 110 form angles of about90 degrees or just under 90 degrees (e.g., about 60 to 120 degrees,about 70 to 110 degrees, or about 80 to 100 degrees) as measured fromthe proximal side 114, and the second bend features 112 form angles ofabout 90 degrees or just under 90 degrees (e.g., about 60 to 120degrees, about 70 to 110 degrees, or about 80 to 100 degrees) asmeasured from the distal side 116.

The first and second bend features 110 and 112 are configured to givethe flexible member 102 a bent configuration when the flexible member102 is in a relaxed state, such that when the flexible member 102 isforced into a stressed state (e.g., by bending the flexible member 102at one or more of the first and/or second bend features 110 and 112),the flexible member 102 is resiliently biased toward the relaxed state.

For example, an arm 106 may be deformed at the second bend feature 112in a manner that flexes the arm 106 in a proximal direction and aninward direction, thereby flexing the arm 106 toward a straighterconfiguration (e.g., increasing the angle of the second bend feature 112as measured from the distal side 116). In such a position, the flexiblemember 102 is in a stressed state such that the arm 106 of the flexiblemember 102 is resiliently biased toward a distal direction and anoutward direction. Other embodiments may omit one or more of the bendfeatures, and other embodiments may include additional bend features.These and other embodiments may include bend features with differingbend angles when in a relaxed state. For example, some embodiments mayinclude bend features that measure greater than about 90 degrees or lessthan about 90 degrees when in a relaxed state.

The flexible member 102 of the illustrated embodiment includes aplurality of holes 118 distributed along the length of each arm 106. Theholes 118 are configured to provide a passage or tie point for one ormore sutures, wires, nitinol wires, rods, cables, polymeric lines, orother such structures. As discussed above, these materials may becoupled to one or more arms 106 to operate as proximal element lines(e.g., element lines 90 illustrated in FIGS. 7A-7C) for raising,lowering, and otherwise manipulating, positioning and/or deploying theflexible member 102. Additionally, or alternatively, the holes 118 maybe configured to provide for the coupling of the flexible member 102 toone or more tissue gripping members (as discussed in detail below).

Other embodiments may include a flexible member with more or less holesand/or with holes in other positions of the flexible member. Forexample, some embodiments may omit holes completely, and someembodiments may include only one hole and/or only one hole per arm.Other embodiments may include holes of different shapes and/or sizes,such as holes formed as slots, slits, or other shapes. In embodimentswhere more than one hole is included, the holes may be uniform in size,shape, and distribution or may be non-uniform in one or more of size,shape, and distribution.

Each arm 106 of the illustrated embodiment includes a furcated section120. The furcated section 120 may extend from the base section 104 to aposition farther along the arm 106 toward the free end 108 of the arm106, as illustrated. In other embodiments, a furcated section may bepositioned at other locations along an arm and/or base section. Otherembodiments may include one or more furcated sections extendingcompletely to the free end of an arm, thereby forming a bifurcated orfork-shaped arm. Other embodiments omit any furcated sections. Thefurcated sections 120 of the illustrated embodiment coincide with thesecond bend features 112. The furcated sections 120 may be configured(e.g., in size, shape, spacing, position, etc.) so as to provide desiredresiliency and/or flexibility at the coinciding second bend features112.

The illustrated embodiment includes a pair of tissue gripping members122, each having a mating surface 124 and a tissue gripping surface 126.Each tissue gripping member 122 includes a plurality of frictionalelements 128 configured to engage with tissue at a treatment site andresist movement of tissue away from the tissue gripping member after thefrictional elements 128 have engaged with the tissue. As shown in theillustrated embodiment, the frictional elements 128 are formed as angledbarbs extending distally and inwardly. In this manner, tissue that isengaged with the frictional elements 128 of a tissue gripping member 122is prevented from moving proximally and outwardly relative to the tissuegripping member 122.

The frictional elements 128 of the illustrated tissue gripping members122 protrude from a side edge 130 of the tissue gripping members 122,thereby forming a plurality of slotted recesses 132 disposed along eachside edges 130 of each tissue gripping member 122 at sections adjacentto the frictional elements 128. Other embodiments may include only onetissue gripping member or may include more than two tissue grippingmembers. For example, some embodiments may include multiple, separatelyformed tissue gripping members configured to be coupled to each arm. Inother embodiments, not every arm includes a corresponding tissuegripping member. Other embodiments may include frictional elements ofvarying size, number, and/or shape. For example, in some embodiments thefrictional elements may be formed as posts, tines, prongs, bands,grooves, channels, bumps, pads, or a combination of these or any otherfeature suitable for increasing friction and/or gripping of contactedtissue.

The tissue gripping members 122 of the illustrated embodiment include aplurality of holes 138 distributed along the length of each tissuegripping member 122. As with the holes 118 of the flexible member 102,the holes 138 of the tissue gripping members 122 are configured toprovide a passage or tie point for one or more sutures, wires, nitinolwires, rods, cables, polymeric lines, or other such structures tooperate as proximal element lines (e.g., element lines 90 illustrated inFIGS. 7A-7C) and/or to provide for the coupling of one or more of thetissue gripping members 122 to the flexible member 102.

The holes 138 of the tissue gripping member 122 of the illustratedembodiment are formed so as to coincide with the holes 118 of theflexible member 102. In this manner, the tissue gripping member 122 maybe positioned relative to the flexible member 102 such that each of theholes 138 of the tissue gripping member 122 align with a correspondinghole 118 of the flexible member 102.

Other embodiments may include a tissue gripping member with more or lessholes and/or with holes in other positions of the tissue grippingmember. For example, some tissue gripping members may omit holes, or mayinclude only one hole. Other embodiments may include holes of differentshapes and/or sizes, such as slots, slits, or other shapes. Inembodiments where more than one hole is included, the holes may beuniform in size, shape, and distribution or may be non-uniform in one ormore of size, shape, and distribution. In other embodiments, not everyhole of the tissue gripping member is configured to align with acorresponding hole of the flexible member and vice versa. In someembodiments, no holes are aligned when the tissue gripping member isproperly positioned relative to the flexible member.

In the illustrated embodiment, the distal side of each arm 106 of theflexible member 102 includes an attachment surface 134. The tissuegripping member 122 is positioned on the distal side of the arm 106 ofthe flexible member 102, with the mating surface 124 of the tissuegripping member 122 facing the attachment surface 134. The tissuegripping member 122 is joined to the flexible member 102 by coupling themating surface 124 to the attachment surface 134. In other embodiments,the mating surface and the attachment surface may be formed withcorresponding press-fit portions or other locking/engaging portionsconfigured to allow the tissue gripping member to be joined to theflexible member by engaging the corresponding press-fit portions and/orother corresponding locking portions. In some embodiments, the tissuegripping member may be fastened to the flexible member by using anadhesive or by welding, soldering, bolting, clamping, riveting, crimpingor otherwise securing the tissue gripping member to the flexible member.

In some embodiments, an arm of the flexible member is configured to bendproximally while moving from a relaxed configuration toward a stressedconfiguration, and to resiliently flex distally toward a relaxedconfiguration when positioned in a stressed configuration, therebyforcing the attachment surface of the arm against the tissue grippingmember as the arm flexed distally toward a relaxed configuration. Forexample, when a tissue gripping device is properly positioned anddeployed at a mitral valve, the arm of the flexible member will operateto “sandwich” the tissue gripping member between the arm and the mitralvalve tissue being gripped.

FIGS. 10A-10C illustrate an embodiment of a tissue gripping device 200wherein the tissue gripping members 222 have been coupled to theflexible member 202. In the illustrated embodiment, each tissue grippingmember 222 has been positioned next to the flexible member 202 byjoining each mating surface (not shown) of each tissue gripping member222 to one of the corresponding attachment surfaces (not shown) of theflexible member 202. In the illustrated embodiment, the tissue grippingmembers 222 are secured to the flexible member 202 by forming sutureloops 240 through the aligned holes 218 and 238 of the flexible member202 and the tissue gripping members 222, respectively. In thisconfiguration, the suture loops 240 can fasten the tissue grippingmember 222 to the flexible member 202 by encircling at least a portionof the tissue gripping member and at least a portion of the arm 206 ofthe flexible member 202 before being tied off, tightened, or otherwisesecured so as to hold the tissue gripping member 222 in position againstthe flexible member 202.

In other embodiments, one or more suture lines may be used to tie orfasten one or more tissue gripping members to the flexible member inother configurations. For example, one or more suture lines may bethreaded or laced through multiple holes on both the tissue grippingmember and the flexible member before being tied off, tightened, orotherwise set in place in order to secure the tissue gripping member tothe flexible member. In other embodiments, one or more suture lines donot pass through any holes. In such embodiments, suture lines may belooped or wrapped around the arm of the flexible member and the tissuegripping member to secure the tissue gripping member to the arm.

The suture line forming the suture loops 240 or other suture fasteningstructures may be wrapped and/or threaded a single time or multipletimes before being tied, tightened, or otherwise set in place. Forexample, some suture lines may be wrapped repeatedly and/or may doubleback on themselves in order to strengthen or further secure the couplingof a tissue gripping member to an arm. In some embodiments one or moreof the suture lines used to form the suture loops 240 or other suturefastening structures may also extend from the tissue gripping device 200to act as the element lines described above (e.g., element lines 90illustrated in FIGS. 7A-7C).

The tissue gripping members 222 of the illustrated embodiment alsoinclude a plurality of slotted recesses 232. In embodiments such asthis, one or more suture loops 240 may be formed such that the sutureline passes through and lodges within oppositely disposed slottedrecesses 232, thereby further aiding in the securing of the tissuegripping member 222 to the arm 206 as well as promoting proper placementof the suture loop 240 and preventing slippage, loosening, or unravelingof the inner suture loop 240 from its proper position.

In other embodiments, suture loops or other suture fastening structuresdo not pass through or lodge within any slotted recesses. Someembodiments may include suture loops and/or suture fastening structuresthat pass through and/or lodge within one or more (not necessarilyoppositely disposed) slotted recesses to aid in fastening the tissuegripping member to the arm of the flexible member. Yet other embodimentsmay include suture lines forming suture loops or other suture fasteningstructures that pass through and/or lodge within one or more slottedrecesses but do not pass through any holes. Conversely, some embodimentsmay include suture lines forming suture loops or other suture fasteningstructures that pass through one or more holes but do not pass thoroughand/or lodge within any slotted recess.

The illustrated embodiment includes two suture loops 240 at each tissuegripping member 222. In other embodiments, more or fewer suture loops orsuture fastening structures may be used, though in preferredembodiments, at least two fastening points are formed (e.g., by usingtwo or more suture loops or by threading or lacing a suture line acrossmultiple points) in order to prevent rotational slippage of the tissuegripping member from the flexible member due to moment forces.

FIGS. 11A-11C illustrate an embodiment of a tissue gripping device 300wherein the tissue gripping members 322 have been coupled to theflexible member 302 using at least one cover 350. The cover 350 ispositioned over at least a portion of the arm 306 of the flexible member302 and over at least a portion of the tissue gripping member 322 so asto hold the tissue gripping member 322 against the arm 306.

In preferred embodiments, the cover 350 is formed as a polymer coverwhich may be formed on the tissue gripping device 300 by dipping,spraying, coating or otherwise adhering it to the surfaces of the tissuegripping device 300 or to portions of the tissue gripping device 300. Insome embodiments, the polymer coating may be applied to the tissuegripping member 322 and the arm 306 (or portions thereof) while thetissue gripping member 322 is held in place against the flexible member306. The polymer coating may then cure, harden, and/or solidify to formthe cover 350 and to hold the tissue gripping member 322 against theflexible member 302. In other embodiments, a polymer coating may act asan adhesive, and the polymer coating may be applied to the matingsurface (not shown) and/or attachment surface (not shown) in order toadhere the tissue gripping member 322 to the arm 306 as the matingsurface is positioned against the attachment surface and the polymercoating is cured.

The cover 350 may be formed in whole or in part of polyethyleneterepthalate, polyester, cotton, polyurethane, expandedpolytetrafluoroethylene (ePTFE), silicon, or various biocompatiblepolymers or fibers and have any suitable form, such as a fabric, mesh,textured weave, felt, looped or porous structure. The cover 350 may alsobe configured to leave the frictional elements 328 (in embodiments thatinclude them) exposed. The cover 350 may also include drugs,antibiotics, anti-thrombosis agents, or anti-platelet agents such asheparin or warfarin sodium. These agents may be impregnated in and/orcoated on the cover 350 such that they are delivered to surroundingtissues and/or the blood stream when the tissue gripping device 300 isimplanted into a patient.

The embodiment illustrated in FIGS. 11A-11C include some covers 350 thatare positioned over the entirety of each tissue gripping member 322 andthe portion of the arms 306 adjacent to each tissue gripping member 322.In other embodiments that include a cover, the cover may be positionedto cover more of the tissue gripping device or even the entirety of thetissue gripping device (e.g., the entire device may be sprayed, dipped,or otherwise coated in a polymer coating that forms the cover).Alternatively, some embodiments may include a cover (such as some of thecovers 350 illustrated in FIGS. 11A-11C) positioned over less of thetissue gripping device such that other portions of the tissue grippingmember and/or arm are exposed (e.g., inner and/or outer portions).

In some embodiments, one or more tissue gripping members may be coupledto an arm of the flexible member using suture lines as discussed withrespect to FIGS. 10A-10C in addition to being held in place using acover as discussed with respect to FIGS. 11A-11C. For example, one ormore suture loops and/or suture fastening structures may be used tofasten one or more tissue gripping members to the flexible member.Afterwards (or alternatively before or at the same time), a polymercoating may be applied to form a cover surrounding at least a portion ofthe tissue gripping member and at least a portion of the coinciding arm.

IV. Methods of Manufacture

Embodiments of tissue gripping devices of the present disclosure may bemanufactured by forming a flexible member from a shape-memory material(such as nitinol). Forming the flexible member may be accomplished bycutting a pattern shape from of shape-memory material sheet stock (oralternatively strip or band stock or other forms of stock). Variousfeatures (e.g., furcated sections, holes, etc.) may optionally be formedin the flexible member either during or after the initial formation ofthe flexible element from the stock material. This may be accomplishedusing any suitable subtractive manufacturing process such as drilling,lathing, die stamping, cutting, or the like. In some embodiments, otherfeatures may be added using an additive manufacturing process. In otherembodiments, no additional features or elements are formed through anysubtractive or additive manufacturing process.

In some embodiments, the flexible member may be further processedthrough a shape setting process. For example, one or more bend featuresmay be formed in the flexible member by subjecting the flexible memberto a heated shape setting process in order to set the shape of the bendin the shape-memory material of the flexible member.

In some embodiments, one or more tissue gripping members are formedseparate from the flexible member. Forming the tissue gripping member(s)may be accomplished through a cutting and/or progressive die stampingprocess of a material having a suitable machinability profile for such amanufacturing process. For example, the material from which the one ormore tissue gripping members are formed may be obtained by cuttingand/or die stamping a shape from sheet stock (or alternatively strip orband stock or other forms of stock). For example, stock material may bestainless steel or a cobalt-chromium alloy, such as acobalt-chromium-nickel alloy or acobalt-chromium-nickel-iron-molybdenum-manganese alloy. In preferredembodiments, the tissue gripping member is formed from Elgiloy®. Variousfeatures (e.g., holes, frictional elements, slotted recesses, etc.) maybe formed on the tissue gripping member as it is formed from the stockmaterial.

In some embodiments, the tissue gripping member may be furthermanufactured through a single or progressive die stamping process. Forexample, the tissue gripping member may be subjected to a progressivedie stamping process in order to form and/or further define a variety offeatures on the tissue gripping member, such as a plurality of raisedbarbs and slotted recesses.

In some embodiments, after formation of the flexible member and thetissue gripping member, the tissue gripping member is attached to theflexible member by coupling a mating surface of the tissue grippingmember (e.g., mating surface 124 of the embodiment of FIGS. 9A-9C) to anattachment surface (e.g., attachment surface 134 of the embodiment ofFIGS. 9A-9C) of the flexible member. The tissue gripping member may thenbe further secured to the flexible member.

For example, one or more suture lines may be wrapped or threaded arounda portion of the tissue gripping member and a portion of the flexiblemember (e.g., an arm portion such as arm 206 of the embodiment of FIGS.10A-10C) as illustrated in the exemplary embodiment of FIGS. 10A-10C.The suture lines may be formed into loops or may be threaded or wrappedaround the tissue gripping member and the arm (or other portion of theflexible member) before being tightened and/or tied off in order tosecure the tissue gripping member to the flexible member.

In some embodiments, the tissue gripping member and/or the flexiblemember may include holes, and the one or more suture lines may be passedthrough one or more of the holes in order to fasten or further securethe tissue gripping member to the flexible member. For example, as shownby the embodiment illustrated in FIGS. 10A-10C, the tissue grippingmember may have a plurality of holes, with each hole configured tocorrespond to a hole on an arm of the flexible member when the tissuegripping member is properly positioned near or against the arm of theflexible member. One or more suture lines may pass through one or morepairs of corresponding holes as it is laced, wrapped, looped, orthreaded around the tissue gripping member and the arm.

In some embodiments, one or more suture lines may also be passed throughor lodged within a slotted recess of the tissue gripping member as it islaced, wrapped, looped, or threaded around the tissue gripping memberand the arm. In such embodiments, the slotted recesses may further aidin securing the suture line in place and/or in preventing loosening,slippage or other unwanted movement of the suture line.

Additionally, or alternatively, the tissue gripping member may besecured to or further secured to the flexible member by adding a coverto the tissue gripping device that inserts over the arm of the flexiblemember and over the tissue gripping member (or portions of such) inorder to hold the tissue gripping member in place against the flexiblemember.

For example, in some embodiments (such as in the embodiment illustratedin FIGS. 11A-11C), the cover may be a polymer material coated onto orotherwise applied to the tissue gripping device (or portions thereof).The polymer coating may then be allowed to set, cure, or otherwise forminto a cover that holds the tissue gripping member in place against thearm of the flexible member. Additionally, or alternatively, the polymercoating may act as an adhesive, and may be applied to the mating surfaceand/or attachment surface to adhere the surfaces together.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A tissue gripping device comprising: a flexiblemember formed from a shape-memory material, the flexible membercomprising a base section and an arm, the arm having a first endconnected to the base section, a free end extending away from the basesection, and an attachment surface disposed between the joining end andthe free end; and at least one tissue gripping member formed from asecond material, the second material being more rigid than theshape-memory material, the tissue gripping member comprising a matingsurface coupled to the attachment surface of the arm to join the tissuegripping member to the flexible member, and a tissue gripping surfacedisposed opposite the mating surface, the tissue gripping surfaceincluding a frictional element configured to resist movement of tissueaway from the tissue gripping surface after the tissue has contacted thetissue gripping surface.
 2. The tissue gripping device of claim 1,wherein the shape-memory material is nitinol.
 3. The gripping fixationdevice of claim 1, wherein the second material is selected from thegroup consisting of: cobalt-chromium alloy, cobalt-chromium-nickelalloy, cobalt-chromium-nickel-iron-molybdenum-manganese alloy, andstainless steel.
 4. The tissue gripping device of claim 1, wherein thefrictional element is formed as a plurality of raised barbs disposedalong a side edge of the tissue gripping member, and wherein the tissuegripping member includes a plurality of slotted recesses disposed alongthe side edge at sections adjacent to the raised barbs.
 5. The tissuegripping device of claim 4, further comprising at least one suture lineencircling at least a portion of the tissue gripping member and at leasta portion of the arm, the suture line being configured to fasten thetissue gripping member to the arm, the suture line passing through andlodging within one or more of the slotted recesses as it encircles thetissue gripping member and the arm.
 6. The tissue gripping device ofclaim 1, wherein the arm further comprises at least one hole, andwherein the tissue gripping member further comprises at least one holeconfigured to correspond with the hole of the arm as the mating surfaceof the tissue gripping member is coupled to the attachment surface ofthe arm.
 7. The tissue gripping device of claim 6, further comprising asuture line configured to fasten the tissue gripping member to the arm,the suture line passing through the hole of the arm and the hole of thetissue gripping member.
 8. The tissue fixation device of claim 1,further comprising a cover, the cover surrounding the arm and the tissuegripping member to hold the tissue gripping member to the flexiblemember.
 9. The tissue fixation device of claim 1, wherein the frictionalelement is formed as a plurality of raised barbs disposed along a sideedge of the tissue gripping member, and wherein the tissue grippingmember includes a plurality of slotted recesses disposed along the sideedge at sections adjacent to the raised barbs, and wherein the armfurther comprises at least one hole and the tissue gripping memberfurther comprises at least one hole configured to correspond with thehole of the arm as the mating surface is coupled to the attachmentsurface, and wherein the tissue fixation device further comprises atleast one suture line encircling at least a portion of the tissuegripping member and at least a portion of the arm, the suture linepassing through the hole of the first or second arm and the hole of thetissue gripping member and passing through and lodging within one ormore of the slotted recesses, and wherein the tissue fixation devicefurther comprises a polymer cover surrounding the arm and the tissuegripping member to hold the tissue gripping member to the flexiblemember.
 10. The tissue fixation device of claim 1, wherein the tissuegripping member is joined to the flexible member by welding or solderingthe mating surface of the tissue gripping member to the attachmentsurface of the arm.
 11. The tissue fixation device of claim 1, whereinthe mating surface of the tissue gripping member includes a press-fitportion, and the attachment surface of the arm includes a correspondingpress-fit portion allowing the tissue gripping member to be joined tothe flexible member by engaging the corresponding press-fit portions.12. The tissue fixation device of claim 1, wherein the arm furthercomprises a proximal side and a distal side, and wherein the attachmentsurface is disposed on the distal side.
 13. The tissue fixation deviceof claim 12, wherein the arm is configured to bend proximally whilemoving from a relaxed configuration toward a stressed configuration, andto resiliently flex distally toward a relaxed configuration whenpositioned in a stressed configuration, thereby forcing the attachmentsurface of the arm against the tissue gripping member as the arm flexesdistally toward a relaxed configuration.
 14. A tissue fixation systemconfigured for intravascular delivery and for use in joining mitralvalve tissue during treatment of the mitral valve, the systemcomprising: a body; a proximal element comprising: a flexible memberformed from a shape-memory material, the flexible member comprising abase section and an arm, the arm having a first end connected to thebase section, a free end extending away from the base section, and anattachment surface disposed between the joining end and the free end;and at least one tissue gripping member formed from a second material,the second material being more rigid than the shape-memory material, thetissue gripping member comprising a mating surface coupled to theattachment surface of the arm to join the tissue gripping member to theflexible member, and a tissue gripping surface disposed opposite themating surface, the tissue gripping surface including a frictionalelement configured to resist movement of tissue away from the tissuegripping surface after the tissue has contacted the tissue grippingsurface; and a distal element having a first end pivotally coupled tothe body and extending to a free second end and a tissue engagementsurface between the first and second end, the tissue engagement surfacebeing configured to approximate and engage a portion of the leaflets ofthe mitral valve, wherein the proximal element is configured tocooperate with the distal element to form a space for receiving aportion of mitral valve tissue therebetween.
 15. The system of claim 14,wherein the frictional element is formed as a plurality of raised barbsdisposed along a side edge of the tissue gripping member, and whereinthe tissue gripping member includes a plurality of slotted recessesdisposed along the side edge at sections adjacent to the raised barbs,and wherein the arm further comprises at least one hole and the tissuegripping member further comprises at least one hole configured tocorrespond with the hole of the arm as the mating surface of the tissuegripping member is coupled to the attachment surface of the arm, and theproximal element further comprising at least one suture line encirclingthe tissue gripping member and the arm, the suture line passing throughthe hole of the arm and the hole of the tissue gripping member andpassing through and lodging within one or more of the slotted recesses.16. The system of claim 14, wherein the shape-memory material is nitinoland the second material is acobalt-chromium-nickel-iron-molybdenum-manganese alloy.
 17. A method ofmanufacturing a tissue gripping device, the method comprising: forming aflexible member from a shape-memory alloy by cutting a pattern shape andheat shape setting at least one bend feature, the flexible membercomprising a base section and an arm, the arm having a first endconnected to the base section, a free end extending away from the basesection, and an attachment surface disposed between the joining end andthe free end, the at least one bend feature being disposed between thefirst end and the free end of the arm; forming a tissue gripping memberfrom a second material by die stamping the second material to form aplurality of raised barbs and a plurality of slotted recesses along theside edge of the tissue gripping member, the second material being morerigid than the shape-memory material, the tissue gripping membercomprising a mating surface and a tissue gripping surface disposedopposite the mating surface; and attaching the tissue gripping member tothe flexible member by coupling the mating surface of the tissuegripping member to the attachment surface of the arm.
 18. The method ofclaim 17, further comprising forming at least one hole in the arm andforming at least one hole in the tissue gripping member that correspondsto the hole of the arm when the mating surface of the tissue grippingmember is coupled to the attachment surface of the arm.
 19. The methodof claim 18, wherein the mating surface is coupled to the attachmentsurface using at least one suture line, the suture line being positionedthrough the hole of the arm and the corresponding hole of the tissuegripping member and encircling at least a portion of the arm and thetissue gripping member to fasten the tissue gripping member to theflexible member.
 20. The method of claim 17, wherein the mating surfaceof the tissue gripping member is coupled to the attachment surface ofthe arm by adding a cover to an area including the arm and the tissuegripping member to hold the tissue gripping member to the flexiblemember.